GMP SOP Writing 101 – What is an SOP Effective date?

GMP SOP Writing 101 – What is an SOP Effective date?

What is an SOP Effective date?

It is surprising how often we review a Standard Operating Procedure (SOP) for a client and the SOP effective date is the same date that QA approved the procedure.

With the speed of light, the authorised document has travelled from the QA manager’s desk, was immediately processed by the Documentation Administration team, distributed and all users affected were trained in the change. That’s one very efficient organisation!

The ‘Guide to Good Manufacturing Practice for Medicinal Products, PE 009-11 (Part 1), Chapter 4, Clause 4.3’ states. ‘The effective date should be defined’ in documents containing instructions.

How much time should be allowed between ‘issued’ and ‘effective’?

To allow for training the effective date generally should be different to the date the document is approved/authorised and issued.

The actual time required to ensure training is conducted should be agreed during the impact assessment of the change approval process based on the number of people to be trained and the type of training required e.g. ‘read-only’ or ‘observed assessment’. Many organisations have a standard time such as two weeks.

What if it is an urgent change?

If the change is urgent, such as an immediate risk to patient safety/product quality, then a change in the process and subsequent training needs to be of higher priority, the effective date should be more closely aligned to the issued date. Regardless of the urgency of the change, your organisation’s training procedures should be followed to ensure appropriate training occurs and training records are completed before employees move to a new process.

Why the time gap?

In order to implement the new process change in a compliant manner then people must be trained in the new procedure BEFORE the document becomes effective. This ensures that by the time the new process is ‘live’ everyone is able to perform the revised activity and training records have been completed.

The effective date is intended to permit the minimum number of people required to implement the change to be trained.

Does this mean there are two live procedures?

No – Before the issued procedure’s effective date the old procedure remains current but, on the day, the revised SOP becomes effective the previous SOP version is superseded and the work practice changes.

Your organisation is replacing one compliance risk for another if you do not utilise effective dates to ensure employee training occurs before the revised process is ‘live’.

Example: Your facility runs two shifts, 70 people during the day shift and 30 during the night shift. The SOP that has been updated appears on the training matrix of all operators and is a task many of the team do daily. The training requires not just read-only of the SOP but an assessment to demonstrate understanding. This means operators will be off the floor for one hour for classroom style training. To ensure manufacturing scheduling is not affected only 10 operators per shift can attend training.

In order to train both day and night shift then a minimum of 7 days needs to be allowed before the document becomes effective (10 operators per day shift, with all night shift trained within 3 nights).

If the SOP effective date is the same as the document approval or issue date, then every operator is instantly non-compliant.

For more information of GMP Good Documentation Practice please have a look at the whitepaper How to implement good documentation practices